PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM
FDA premarket approval P030017/S053 · decided 2010-06-15
Approval details
- PMA number
- P030017
- Supplement
- S053
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Boston Scientific Corp
- Date received
- 2008-03-24
- Decision date
- 2010-06-15
- Days to decision
- 813 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Valencia, CA
- Statement
- Approval for IPG/ETS Firmware Revision 3.02.
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